Preventive intraperitoneal hyperthermic perfusion chemotherapy for patients with T4 stage colon adenocarcinoma

Li, T; Yu, Juan; Y, Chen; Liu, R; Li, Y; Wang, Y X; Wang, J J; Zhu, Pengfei

doi:10.1007/s10151-020-02270-1

Cited by 7 publications

(6 citation statements)

References 30 publications

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“…12,[21][22][23][24][25][26] The reported rates of major complications related to adjuvant HIPEC were low. 12 A recent retrospective comparative trial 27 that included 352 patients with pT4N02M0 disease compared postoperative HIPEC with surgery alone in which the HIPEC protocol was lobaplatin in the early postoperative period (days 2-7). The rates of peritoneal recurrence were significantly lower for the HIPEC group than for the comparator group (26.1% vs 37.4%).…”

Section: Discussionmentioning

confidence: 99%

“…The rates of peritoneal recurrence were significantly lower for the HIPEC group than for the comparator group (26.1% vs 37.4%). 27 Baratti et al 28 conducted a comparative trial and reported a 9.3% incidence of peritoneal metastases at 5 years after surgery compared with a 42.5% incidence in case-matched controls. Substantial biases in the methods were observed among the aforementioned studies 27,28 ; however, their promising results have encouraged other teams to design RCTs.…”

Section: Discussionmentioning

confidence: 99%

“…A recent retrospective comparative trial that included 352 patients with pT4N02M0 disease compared postoperative HIPEC with surgery alone in which the HIPEC protocol was lobaplatin in the early postoperative period (days 2-7). The rates of peritoneal recurrence were significantly lower for the HIPEC group than for the comparator group (26.1% vs 37.4%) . Baratti et al conducted a comparative trial and reported a 9.3% incidence of peritoneal metastases at 5 years after surgery compared with a 42.5% incidence in case-matched controls.…”

Section: Discussionmentioning

confidence: 99%

“…Baratti et al conducted a comparative trial and reported a 9.3% incidence of peritoneal metastases at 5 years after surgery compared with a 42.5% incidence in case-matched controls. Substantial biases in the methods were observed among the aforementioned studies; however, their promising results have encouraged other teams to design RCTs. Two multi-institutional RCTs have evaluated the role of prophylactic HIPEC in reducing the incidence of peritoneal metastases in patients with high-risk colon cancer.…”

Section: Discussionmentioning

confidence: 99%

“…The mean (SD) age was 61.5 (9.2) years, and 111 (60.3%) were male. Median duration of follow-up was 36 months (IQR,(27)(28)(29)(30)(31)(32)(33)(34)(35)(36). Demographic and clinical characteristics were similar between groups.…”

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confidence: 99%

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Efficacy and Safety of Intraoperative Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Colon Cancer

et al. 2023

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ImportancePeritoneal metastasis in patients with locally advanced colon cancer (T4 stage) is estimated to recur at a rate of approximately 25% at 3 years from surgical resection and is associated with poor prognosis. There is controversy regarding the clinical benefit of prophylactic hyperthermic intraperitoneal chemotherapy (HIPEC) in these patients.ObjectiveTo assess the efficacy and safety of intraoperative HIPEC in patients with locally advanced colon cancer.Design, Setting, and ParticipantsThis open-label, phase 3 randomized clinical trial was conducted in 17 Spanish centers from November 15, 2015, to March 9, 2021. Enrolled patients were aged 18 to 75 years with locally advanced primary colon cancer diagnosed preoperatively (cT4N02M0).InterventionsPatients were randomly assigned 1:1 to receive cytoreduction plus HIPEC with mitomycin C (30 mg/m2 over 60 minutes; investigational group) or cytoreduction alone (comparator group), both followed by systemic adjuvant chemotherapy. Randomization of the intention-to-treat population was done via a web-based system, with stratification by treatment center and sex.Main Outcomes and MeasuresThe primary outcome was 3-year locoregional control (LC) rate, defined as the proportion of patients without peritoneal disease recurrence analyzed by intention to treat. Secondary end points were disease-free survival, overall survival, morbidity, and rate of toxic effects.ResultsA total of 184 patients were recruited and randomized (investigational group, n = 89; comparator group, n = 95). The mean (SD) age was 61.5 (9.2) years, and 111 (60.3%) were male. Median duration of follow-up was 36 months (IQR, 27-36 months). Demographic and clinical characteristics were similar between groups. The 3-year LC rate was higher in the investigational group (97.6%) than in the comparator group (87.6%) (log-rank P = .03; hazard ratio [HR], 0.21; 95% CI, 0.05-0.95). No differences were observed in disease-free survival (investigational, 81.2%; comparator, 78.0%; log-rank P = .22; HR, 0.71; 95% CI, 0.41-1.22) or overall survival (investigational, 91.7%; comparator, 92.9%; log-rank P = .68; HR, 0.79; 95% CI, 0.26-2.37). The definitive subgroup with pT4 disease showed a pronounced benefit in 3-year LC rate after investigational treatment (investigational: 98.3%; comparator: 82.1%; log-rank P = .003; HR, 0.09; 95% CI, 0.01-0.70). No differences in morbidity or toxic effects between groups were observed.Conclusions and RelevanceIn this randomized clinical trial, the addition of HIPEC to complete surgical resection for locally advanced colon cancer improved the 3-year LC rate compared with surgery alone. This approach should be considered for patients with locally advanced colorectal cancer.Trial RegistrationClinicalTrials.gov Identifier: NCT02614534

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